我国医学人工智能发展监管现状及政策建议

Regulatory Status and Policy Recommendations for the Development of Medical Artificial Intelligence in China

目的/意义 医学人工智能应用监管碎片化及数据的高门槛现状与医学人工智能发展需求之间矛盾日益突显。在各国积极部署数字健康战略的背景下,如何主动作为、为我国医学人工智能发展做好政策护航已成为亟待解决的问题。方法/过程 基于面向“产-学-研-用-管”多领域开展的调查研究及深度访谈资料,系统梳理医学人工智能特点及发展诉求,从国家战略和行业政策层面对当前监管体系现状进行分析。结果/结论 提出“构建医学人工智能监管衔接机制”的整体政策建议,从组织衔接、数据衔接、人才衔接和技术支撑4个角度展开,为破除当前发展壁垒、促进我国医学人工智能健康蓬勃发展提供解决思路。

Purpose/Significance With the gradual deepening of the application of medical artificial intelligence(AI),the contradiction between the fragmentation of regulation and the high threshold status quo of data and the development needs of medical AI has become increasingly prominent.In the context of the active deployment of digital health strategies by countries around the world,how to take the initiative to act and do a good job of policy escort for the development of medical AI in China has become an urgent problem to be solved now.Method/Process Based on the investigation and research and in-depth interview data in the fields of“industry-university-research-use-management”,the paper systematically sorts out the characteristics and development demands of medical AI,and analyzes the current status of the regulatory system from the national strategic level and the industry policy level.Result/Conclusion From the perspective of organizational convergence,data convergence,talent convergence,and technology support,it is proposed to build a regulatory convergence mechanism to provide solution ideas for breaking down the current development barriers and promoting the healthy and prosperous development of medical AI in China.